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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Non-Electric
510(k) Number K893636
Device Name GUARDIAN FORCEP
Applicant
Endo-Scientific, Inc.
600 Greenwood Ave. N., #B
Clearwater,  FL  34615
Applicant Contact HAL P ZINNECKER
Correspondent
Endo-Scientific, Inc.
600 Greenwood Ave. N., #B
Clearwater,  FL  34615
Correspondent Contact HAL P ZINNECKER
Regulation Number876.1075
Classification Product Code
FCL  
Date Received05/12/1989
Decision Date 04/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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